Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.

NCT03492567 | Completed

• 2 other identifiers: K171004J2017-A02965-48
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis. Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. These latter cells are responsible for bone degradation and therefore promote the increase of bone fragility. The research will focus on the characterization of these cells to better understand their potential (low, medium or high) to increase bone fragility in patients with cystic fibrosis. Finally the action of CFTR modulators on these bone cells will be tested.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; CFTR; CFTR modulators; Monocyte; Osteoclast; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Phenotype of CD14 monocytes/osteoclasts

  1 day

Secondary Outcomes (1)

• In vitro test of CFTR modulators

  1 day

Study Arms (1)

Blood monocyte precursors/osteoclasts

EXPERIMENTAL

Blood test

Biological: Blood test

Interventions

Blood test BIOLOGICAL

Blood draw (max 15 ml)

Blood monocyte precursors/osteoclasts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with cystic fibrosis
• attending the Paris Cochin adult CF centre
• with at least F508del mutation (homozygote or heterozygote patients)

You may not qualify if:

• patients younger than 18
• absence of signed consent
• patients without a F508del mutation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Vaincre la Mucoviscidose: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, Paris, 75014, France

Location

Related Publications (1)

• Jourdain ML, Sergheraert J, Braux J, Guillaume C, Gangloff SC, Hubert D, Velard F, Jacquot J. Osteoclastogenesis and sphingosine-1-phosphate secretion from human osteoclast precursor monocytes are modulated by the cystic fibrosis transmembrane conductance regulator. Biochim Biophys Acta Mol Basis Dis. 2021 Mar 1;1867(3):166010. doi: 10.1016/j.bbadis.2020.166010. Epub 2020 Nov 11.

  PMID: 33188942 RESULT

MeSH Terms

Conditions

Cystic Fibrosis; Osteoporosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dominique HUBERT, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 10, 2018
• Study Start: April 25, 2018
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

FR (1)